April 20, 2007

Rights to drugs sought

Star: SUBANG JAYA: Malaysia wants to reserve the right to import any patented drug and also wants the right to produce it locally if it is in the national interest or use it for natural disasters or non-profit purposes.
Health Minister Datuk Seri Dr Chua Soi Lek said Malaysia reserved the right to compulsory licensing under the Patent Act.
“We want to exercise our rights if a certain drug is important to us,” he said after presenting Pharmaniaga’s Excellence Vendors Awards 2006.
The right to compulsory licensing is among the topics of discussions in the Free Trade Agreement talks with the United States.
Dr Chua said drug prices would not be affected through the country’s exercising of its rights but it would give intellectual property protection to the local industry.
He cited the mostly patented anti-retroviral drugs for HIV/AIDS patients as an example.
He said Malaysia started importing the drugs from India in 2004 and managed to bring down prices from RM1,200 per month for a patient to RM200. The price has since been brought down further to RM150 a month as the drugs were now produced in Malaysia.
Dr Chua also rejected a US request that patents for diagnostic, therapeutic and surgical procedures for humans and animals should be granted.
“A procedure should not be patented. If it is patented by a doctor, then other doctors cannot use the same method,” he said.
He said Malaysia would allow data exclusivity (DE) for pharmaceutical products for five years from the same date as in the country of origin and that the decision to give DE was under the purview of the Drug Regulatory Authority.
The minister said that no DE would be given to pharmaceutical companies that merely changed the strength of dosage of a product or how it was presented.
However, DE would be given for a new indication of a known product.
DE happens when a company creates a new product and has to submit all information to the ministry’s Drug Regulatory Authority in order to market it. The data then becomes exclusive rights of that company.